Gilead Sciences, Inc. (GILD) Announces Results from Phase 3 Trials
Gilead Sciences, Inc. (NASDAQ:GILD) disclosed the outcome of Phase three trials of its investigational, once-a-day, single tablet regimen for treatment of HIV-1 infection in adults that are treatment-naïve. The regimen also contained tenofovir alafenamide or TAF. The company stated that the results were statistically non-inferior to its Stirbild.
Gilead Sciences, Inc. (NASDAQ:GILD) announced two phase three trials. The company’s detailed data were presented at a Conference on Retroviruses and Opportunistic Infections held in Seattle. Its presentations were in two late-breaker sessions O-10 and O-11 detailing the results of 48-weeks of its studies.
The company stated that its second analysis also found better response from patients who were given the TAF regimen. Patients found better renal, as well as bone laboratory parameters, compared to those who were treated with Stribild. The pharmaceutical firm said that TAF was an innovative nucleotide reverse transcriptase inhibition or NRTI, which demonstrated an antiviral efficacy of ten times lower than Viread.
Gilead Sciences, Inc. (NASDAQ:GILD) said that 1,733 treatment-naïve adults, with HIV, were randomized to get Stribild. At the end of the 48 weeks, 92.4% of patients, who took E/C/F/TAF, achieved HIV RNA levels of less than 50 copies/mL. Similarly, 90.4% of the patients who took Stribild also achieved a similar level of less than 50 copies/mL.
Professor of Medicine at Harvard Medical School and a Clinical Director of Brigham and Women’s Hospital, Paul Sax, said that there were ongoing concerns about long-term renal and bone health. This was so particularly with HIV patients living longer and waiting for treatment of antiretroviral for a greater period. The medical expert said that the results only demonstrated that a TAF-based single tablet has the potential of helping to address HIV patients’ needs as they are facing life-long therapy of antiretroviral.
Gilead Sciences, Inc. (NASDAQ:GILD) said that it filed a New Drug Application with the Food and Drug Administration on November 5. The regulator has set a target action date of November 5 in the current year under the Prescription Drug User Fee Act. It would be the first tablet with TAF if approved. The company has also filed for a Marketing Authorization Application or MAA in the European Union on December 23 last year.
Latest posts by Viraj Shah (see all)
- Tesla Motors Inc (NASDAQ:TSLA)’s Elon Musk Is Going After Semi Truck Industry - November 17, 2017 04:37 AM PDT
- Tesla Motors Inc (NASDAQ:TSLA) Is Not “Hotbed for Racist Behavior” - November 15, 2017 06:58 AM PDT
- Nikola Tesla and Tesla Motors Inc (TSLA) – The Past & Future of the World You Cannot Ignore- Part 1 - May 15, 2017 05:11 AM PDT